EXALT Model B Single-Use Bronchoscope
FDA 510(k) K222014 · Boston Scientific Corporation
510(k) numberK222014
Submission
- Device name
- EXALT Model B Single-Use Bronchoscope
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- July 8, 2022
- Decision date
- July 28, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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Questions and answers
When was EXALT Model B Single-Use Bronchoscope cleared by the FDA?
EXALT Model B Single-Use Bronchoscope (K222014) received a 510(k) decision of Substantially Equivalent on July 28, 2022, 20 days after the submission was received.
What is the product code of K222014?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.